LL100 CRYOSURGICAL SYSTEM

Unit, Cryosurgical, Accessories

WALLACH SURGICAL DEVICES, INC.

The following data is part of a premarket notification filed by Wallach Surgical Devices, Inc. with the FDA for Ll100 Cryosurgical System.

Pre-market Notification Details

Device IDK803311
510k NumberK803311
Device Name:LL100 CRYOSURGICAL SYSTEM
ClassificationUnit, Cryosurgical, Accessories
Applicant WALLACH SURGICAL DEVICES, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeGEH  
CFR Regulation Number878.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-01-02
Decision Date1981-02-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00888937002836 K803311 000
00888937002669 K803311 000

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